Trial document




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  DRKS00013614

Trial Description

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Title

cENZIAN versus ENZIAN – An observational multicenter study on
the prediction of a preoperative to an intraoperative ENZIAN classification for
endometriosis surgery.

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Trial Acronym

cENZIAN-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The planned number of participants is 900-1000 patients. The study is a pure observational study without risk for the study participants.

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Brief Summary in Scientific Language

This multicenter study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The study is to be classified as a non-interventional method study (classification of the cENZIAN classification as a new diagnostic method without any risk for the study participants). The planned number of participants is 900-1000 patients.

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Organizational Data

  •   DRKS00013614
  •   2017/12/22
  •   [---]*
  •   yes
  •   Approved
  •   1002/2017, Ethikkommission des Landes Oberösterreich
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N80 -  Endometriosis
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Interventions/Observational Groups

  •   In patients with a planned endometriosis surgery, the common diagnostic measures are carried out routinely (depending on the use or need: palpation/speculum, ultrasound, MRI or further imaging), regardless of the study. The responsible physician will then fill out the section "cENZIAN" in the questionnaire for each diagnostic measure. At the end of the surgical procedure, the surgeon records his intraoperative impressions under the heading "ENZIAN". This concludes the study participation of the patient.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Austria
  •   Germany
  •   Czech Republic
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/01/16
  •   900
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Informed consent to participate in the study after preceding written and verbal information
• Suspected or confirmed endometriosis with planned surgery within 6 months
• Ability to consent
• Age > 18 years

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Exclusion Criteria

Inapplicability of the diagnostic procedures routinely provided for preoperative endometriosis-specific knowledge acquisition (e.g. gynecological examination, ultrasound or other imaging)

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Addresses

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    • Kepler Universitätsklinikum
    • 4020  Linz
    • Austria
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    • Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
    • Mr.  Dr.  Simon-Hermann  Enzelsberger 
    • Krankenhausstraße 26-30
    • 4020  Linz
    • Austria
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    • Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
    • Mr.  Dr.  Simon-Hermann  Enzelsberger 
    • Krankenhausstraße 26-30
    • 4020  Linz
    • Austria
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Sources of Monetary or Material Support

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    • Kepler Universitätsklinikum
    • 4020  Linz
    • Austria
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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